Indications, Safety, and Warnings
INTENDED USE / INDICATIONS FOR USE
The IntellaTip MiFi™ OI Catheter, when used with a compatible Radiofrequency Controller and Irrigation Pump, is indicated for:
• Cardiac electrophysiological mapping
• Delivering diagnostic pacing stimuli
• RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older
• Treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system.
The IntellaTip MiFi OI Catheter is contraindicated for use in patients:
• With active systemic infection;
• With a mechanical prosthetic heart valve through which the catheter must pass;
• Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation;
• Who have vena cava embolic protection filter devices and/ or known femoral thrombus who require catheter insertion from the femoral approach;
• Who are hemodynamically unstable;
• Who have myxoma or an intracardiac thrombus;
• Who have had a ventriculotomy or atriotomy within the preceding eight weeks;
• Who have had a Patent Foramen Ovale (PFO) occlusion device
Note: The INTELLATIP MIFI OI Catheter is not designed to be compatible with the MAESTRO 3000™ Cardiac Ablation System.
• Using the IntellaTip MiFi OI Catheter at lower than prescribed flow rate may increase the potential for thrombus, coagulum, and char that may result in embolism.
• Patients undergoing an atrial flutter ablation are at risk for complete Atrioventricular (AV) block which requires the implantation of a temporary and or permanent pacemaker.
• There are no data to support the safety and effectiveness of this device in the pediatric population.
• Because the long term effects of exposure to ionizing radiation are unknown, careful consideration should therefore be given to pregnant women and prepubescent children.
• In the presence of anticoagulation, there may be an increased risk of bleeding from all causes.
• Stimulation of cardiac tissues caused by pacing stimulus and/or RF energy may lead to inadvertent induction of arrhythmias. These arrhythmias may require defibrillation that could also result in skin burns.
• Warnings for patients with implantable pacemakers and implantable cardioverter/defibrillators (ICDs):
• Temporarily adjust tachytherapy settings of an ICD per the manufacturer guidelines during RF ablation as the device could reset or deliver inappropriate defibrillation therapy resulting in patient injury. The ICD could be damaged by the ablation procedure. Interrogate the device fully after the ablation per the manufacturer guidelines and reactivate the ICD’s pre-operative pacing, sensing, and therapy parameters after the ablation procedure.
• Temporarily reprogram the pacemaker per the manufacturer guidelines during RF ablation to a nontracking pacing mode if pacing is likely to be required during the ablation. The pacemaker could be damaged by the ablation procedure. Interrogate the device fully after the ablation per the manufacturer guidelines and reprogram to preoperative sensing and pacing parameters.
• Have temporary external sources of pacing and defibrillation available.
• Fluoroscopic guidance and care must be taken during catheter advancement, manipulation, and withdrawal to avoid lead dislodgment.
• Catheter entrapment within the heart or blood vessels is a possible complication of cardiac ablation procedures. The potential for catheter entrapment may be increased when the catheter is overtorqued and/or positioned in the chordae tendinae. The occurrence of this complication may necessitate surgical intervention and/or repair of injured tissue and/or valve damage.
• Prior to the procedure, always identify the patient’s risk of volume overload. Monitor the patient’s fluid balance throughout the procedure and after the procedure to avoid fluid volume overload. Some patients may have factors that reduce their ability to handle the volume overload, making them susceptible to developing pulmonary edema or heart failure during or after the procedure. Patients with congestive heart failure or renal insufficiency, and the elderly are particularly susceptible.
• Patients with hemodynamic instability or cardiogenic shock are at increased risk for life-threatening adverse events and ablation must be done with extreme caution.
• This IntellaTip MiFi OI Catheter is not intended to be used for internal cardioversion. Doing so may result in perforation, arrhythmias, embolism, thrombus and/or patient death.
• The long-term risks of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown.
• If there is uncertainty regarding the patient’s anticoagulation status or rhythm prior to the atrial flutter procedure, there should be a low threshold to perform a transesophageal echocardiogram (TEE) prior to the procedure to confirm absence of mural thrombus and/or thrombus in the left atrial appendage.
• The IntellaTip MiFi OI Catheter contains Bis (2-ethyhexyl) phthalate (DEHP). BSC has assessed the residual patient risk associated with phthalates in this device to be minimal; however, BSC has not assessed the residual patient risk associated with phthalates which may be contained in non-BSC ancillary devices required for use in conjunction with the IntellaTip MiFi OI Catheter
• Patients undergoing a long irrigated ablation procedure have the potential for greater anticoagulation and therefore Activated Coagulation Time (ACT) should be monitored closely.
POTENTIAL ADVERSE EVENTS
Potential adverse events which may be associated with catheterization and ablation include:
• Allergic reaction (including anaphylaxis)
• Arrhythmias (new or exacerbation of existing arrhythmias)
• Cardiac perforation
• Cardiac/respiratory arrest
• Catheter entrapment
• Cerebrovascular accident (CVA)
• Chest discomfort
• Conduction pathway injury
• Complete heart block (transient/permanent)
• Complications of sedative agents/anesthesia
• Congestive heart failure
• Effusion (pericardial/pleural)
• Embolism (venous/arterial) (e.g., air embolism, cerebrovascular accident, Myocardial Infarction (MI), pulmonary embolism)
• Esophageal injury
• Exacerbation of existing conditions
• Fistula (arterial-venous/atrio-esophageal)
• Fluid volume overload
• Gastroparesis/Gastrointestinal (GI) events
• Inadvertent injury to adjacent structures
• Lead dislodgement
• Myocardial infarction
• Nerve injury (phrenic/vagus)
• Pulmonary/pedal edema
• Pulmonary vein stenosis
• Radiation exposure
• Renal insufficiency/failure
• Residual Atrial Septal Defects (ASD)
• Skin burns (radiation/defibrillator/cardioverter)
• Transient ischemic attack (TIA)
• Valvular damage
• Vasovagal reactions
• Vessel trauma (perforation/dissection/rupture)
92096509 (Rev. B)